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7 FDA 510(k) clearances · Product code

FDA profile

Official device name

Powered Light Based Non-Laser Surgical Instrument

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4810

Medical specialty

General, Plastic Surgery

Flags

Third-party review eligible

FDA definition

A light based Non-Laser device typically indicated to be used for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. Indication for Use can be general and/or specific. The classification regulation 21 CFR 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.

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